Has a generic version of Advair HFA been approved?

No. There is currently no therapeutically equivalent version of Advair HFA available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Advair HFA. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Aerosol formulations containing propellant 134a and fluticasone propionatePatent 5,658,549Issued: August 19, 1997Inventor(s): Akehurst; Rachel Ann & Taylor; Anthony James & Wyatt; David AndrewAssignee(s): Glaxo Group LimitedThis invention relates to aerosol formulations of use for the administration of medicaments by inhalation, in particular a pharmaceutical aerosol formulation which comprises particulate medicament selected from the group comprising salmeterol, salbutamol, fluticasone propionate and physiologically acceptable salts and solvates thereof and a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant, which formulation is substantially free of surfactant. A method of treating respiratory disorders which comprises administration by inhalation of an effective amount of a pharmaceutical aerosol formulation as defined is also described.

Patent expiration dates:

August 19, 2014

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Patent use: INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS OF AGE OR OLDER

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Drug product

February 19, 2015

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Pediatric exclusivity

Canisters containing aerosol formulations containing P134a and fluticasone propionatePatent 5,674,472Issued: October 7, 1997Inventor(s): Akehurst; Rachel Ann & Taylor; Anthony James & Wyatt; David AndrewAssignee(s): Glaxo Group LimitedThe present invention relates to canisters suitable for delivering a pharmaceutical aerosol formulation which comprises a container capable of withstanding the vapor pressure of the propellant used, which container is closed with a metering valve and contains a pharmaceutical aerosol formulation consisting essentially of a particulate medicament which is fluticasone propionate or a physiologically acceptable solvate thereof and 1,1,1,2-tetrafluoroethane as propellant, which formulation contains less than 0.0001% w/w surfactant based on the weight of the medicament, the particulate medicament being present in an amount from 0.005% to 5% w/w relative to the total weight of the formulation and having a particle size of less than 100 microns. A further particulate medicament may also be present in the pharmaceutical aerosol formulation.

Patent expiration dates:

October 7, 2014

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Drug product

April 7, 2015

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Pediatric exclusivity

Indicating devicePatent 6,161,724Issued: December 19, 2000Inventor(s): Blacker; Richard & Engelbreth; Daniel K. & Schmidt; James N.Assignee(s): 1263152 Ontario Inc.An indicating device for use with a dispensing device that dispenses metered dosages of a medicament from a container having a valve moveable between an open and closed position. In a preferred embodiment, the container is reciprocally moveable within the housing along a longitudinal axis. The housing preferably has a well adapted to receive a valve stem and an exhaust port. The well communicates with the port such that the metered dosage of medicament is dispensed through the port when the valve is moved to the open position. An indicator assembly comprises an indicator member that includes dosage indicia visible to a user. In a preferred embodiment, the indicator assembly is provided in an indicator module. A method for dispensing measured dosages is also provided, along with a kit capable of being assembled as an inhalation device. A delivery system having a key member and a key entry passageway is also provided.

Patent expiration dates:

January 16, 2018

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Drug product

July 16, 2018

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Pediatric exclusivity

Valve for aerosol containerPatent 6,170,717Issued: January 9, 2001Inventor(s): Di Giovanni; Patrick & Rogerson; Cheryl VanessaAssignee(s): Glaxo Wellcome Inc.Valve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein. The valve comprises a valve body (1) having at least one orifice (16) to allow a quantity of the suspension to pass from the container into the valve. The valve further comprises a ring (18) disposed around the valve body (1), the ring being positioned below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom, the ring having at least one portion of reduced axial thickness to provide a trough (19) around the valve body below the at least one orifice.

Patent expiration dates:

December 23, 2017

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Drug product

June 23, 2018

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Pediatric exclusivity

Valve for aerosol containerPatent 6,315,173Issued: November 13, 2001Inventor(s): Di Giovanni; Patrick & Rogerson; Cheryl VanessaAssignee(s): SmithKline Beecham CorporationValve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein The valve comprises a valve body (1) having at least one orifice (16) to allow a quantity of the suspension to pass from the container into the valve. The valve further comprises a ring (18) disposed around the valve body (1), the ring being positioned below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom, the ring having at least one portion of reduced axial thickness to provide a trough (19) around the valve body below the at least one orifice.

Patent expiration dates:

December 23, 2017

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Drug product

June 23, 2018

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Pediatric exclusivity

Dispenser with doses′ counterPatent 6,431,168Issued: August 13, 2002Inventor(s): Paul Kenneth; Rand & Peter John; Brand & James William; Godfrey & Stanley George; BonneyAssignee(s): Smithkline Beecham CorporationThere is provided a dispenser suitable for dispensing medicament, particularly medicament for use in the treatment of respiratory disorders. The dispenser comprises a housing (1) having a support (5); a container (2), locatable within said housing (1), having an outlet member, wherein said container (2) is movable relative to the housing (1) to enable dispensing therefrom and said outlet member is connectable with said support (5) to prevent relative movement there-between; and a dose indicator (13, 43), locatable within said housing (1). The container (2) and dose indicator (13, 43) are reversably removable from the housing (1) as a single unit.

Patent expiration dates:

June 8, 2018

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Drug product

December 8, 2018

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Pediatric exclusivity

Delivery system for a medicament and method for the assembly thereofPatent 6,435,372Issued: August 20, 2002Inventor(s): Richard; Blacker & Daniel K.; Engelbreth & James N.; SchmidtAssignee(s): 1263152 Ontario Inc.An indicating device for use with a dispensing device that dispenses metered dosages of a medicament from a container having a valve moveable between an open and closed position. In a preferred embodiment, the container is reciprocally moveable within the housing along a longitudinal axis. The housing preferably has a well adapted to receive a valve stem and an exhaust port. The well communicates with the port such that the metered dosage of medicament is dispensed through the port when the valve is moved to the open position. An indicator assembly comprises an indicator member that includes dosage indicia visible to a user. In a preferred embodiment, the indicator assembly is provided in an indicator module. A method for dispensing measured dosages is also provided, along with a kit capable of being assembled as an inhalation device. A delivery system having a key member and a key entry passageway is also provided.

Patent expiration dates:

January 16, 2018

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Drug product

July 16, 2018

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Pediatric exclusivity

Valve for aerosol containerPatent 6,510,969Issued: January 28, 2003Inventor(s): Patrick; Di Giovanni & Cheryl Vanessa; RogersonAssignee(s): SmithKline Beecham CorporationValve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein. The valve comprises a valve body (1) having at least one orifice (16) to allow a quantity of the suspension to pass from the container into the valve. The valve further comprises a ring (18) disposed around the valve body (1), the ring being positioned below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom, the ring having at least one portion of reduced axial thickness to provide a trough (19) around the valve body below the at least one orifice.

Patent expiration dates:

December 23, 2017

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Drug product

December 23, 2017

June 23, 2018

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Pediatric exclusivity

Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosolPatent 6,596,260Issued: July 22, 2003Inventor(s): Fran&ccedil;ois; Brugger & Angelika; StampfAssignee(s): Novartis CorporationThe invention relates to an aerosol container for pharmaceutically active aerosols that are to be administered in predetermined amounts and that are supplied in the container in the form of a suspension, the suspension also comprising, in addition to a pharmaceutically active substance, at least a propellant gas. The aerosol container has a metering valve that comprises a metering chamber and a valve stem. In a first position of the valve stem, the metering chamber is in communication with the interior of the container and has been filled with a predetermined amount of the aerosol. In a second position of the valve stem, the amount of aerosol disposed in the metering chamber is released. The propellant gas is an alternative propellant gas that is free of fluorochlorohydrocarbons, preferably a propellant gas that comprises only fluorohydrocarbons, and the inner wall of the container is coated with a plastics coating.

Indicating devicePatent 6,938,796Issued: September 6, 2005Inventor(s): Blacker; Richard & Engelbreth; Daniel K. & Schmidt; James N.Assignee(s): 1263152 Ontario Inc.A device for dispensing metered dosages of a substance from a container includes a dispenser housing and an indicating device. The indicating device includes an indicator housing, at least one engagement member disposed in the indicator housing, a plurality of indicator members coaxially mounted in the indicator housing, and an actuator coupled to and moveable with the container relative to the plurality of indicator members and the dispenser housing. The actuator member is selectively engaged with at least one of indicator members and is operative to advance the at least one indicator member an incremental amount. The at least one engagement member is selectively engaged with an advancement member so as to bias the advancement member into operable engagement with at least one of the indicator members and move the at least one indicator member an incremental amount. A method for dispensing metered dosages of the substance is also provided.

Patent expiration dates:

January 16, 2018

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Drug product

July 16, 2018

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Pediatric exclusivity

Valve for aerosol containerPatent 6,966,467Issued: November 22, 2005Inventor(s): Di Giovanni; Patrick & Rogerson; Cheryl VanessaAssignee(s): SmithKlineBeecham CorporationValve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein. The valve comprises a valve body (1) having at least one orifice (16) to allow a quantity of the suspension to pass from the container into the valve. The valve further comprises a ring (18) disposed around the valve body (1), the ring being positioned below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom, the ring having at least one portion of reduced axial thickness to provide a trough (19) around the valve body below the at least one orifice.

Patent expiration dates:

December 23, 2017

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Drug product

June 23, 2018

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Pediatric exclusivity

Indicating devicePatent 6,997,349Issued: February 14, 2006Inventor(s): Blacker; Richard & Engelbreth; Daniel K. & Schmidt; James N.Assignee(s): Trudell Medical InternationalA dispenser for dispensing metered dosages of a substance from a container includes a dispenser housing having a top, a bottom, a longitudinally extending cavity open at the top, and a support block extending from the bottom into the cavity. The container includes an end portion, a valve stem extending from the end portion and a valve moveable between a closed position and an open position. An indicating device is disposed in the cavity of the dispenser housing. The indicating device includes a collar disposed around and secured to the end portion of the container and an indicator including dosage indicia. The indicator is disposed in the cavity beneath the end portion of the container

Patent expiration dates:

January 16, 2018

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Drug product

July 16, 2018

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Pediatric exclusivity

Dispenser with doses' counterPatent 7,107,986Issued: September 19, 2006Inventor(s): Rand; Paul Kenneth & Brand; Peter John & Godfrey; James WilliamAssignee(s): Glaxo Group LimitedThere is provided a dispenser suitable for dispensing medicament, particularly medicament for use in the treatment of respiratory disorders. The dispenser comprises a housing having a support; a container, locatable within said housing, having an outlet, wherein said container dispenses through said outlet in response to movement of the container relative to the housing; and an actuation indicator having an indexing mechanism actuatable by movement of the container relative to the housing. A couple mechanism is provided which couples the indexing mechanism to the container to compensate for any variation in pre-actuation positionings of the indexing mechanism and container.

Patent expiration dates:

June 8, 2018

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Drug product

December 8, 2018

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Pediatric exclusivity

Indicating devicePatent 7,143,908Issued: December 5, 2006Inventor(s): Blacker; Richard & Engelbreth; Daniel K. & Schmidt; James N.Assignee(s): Trudell Medical InternationalA device for dispensing metered dosages of a substance from a container includes a dispenser housing having a longitudinally extending cavity defined at least in part by a wall and a support block spaced from the wall. The container is disposed in the cavity of the dispenser housing and is container reciprocally moveable within the dispenser housing along a longitudinal axis. An indicating device is disposed in the dispenser housing and includes an annular member disposed around a first end of the container with a valve stem of the container extending beyond the annular member. The indicating device includes at least one indicator member rotatable about an axis of rotation. At least a portion of the indicating device is fixedly connected to the container and is reversibly removable with the container from the dispenser housing.

Patent expiration dates:

January 16, 2018

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Drug product

July 16, 2018

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Pediatric exclusivity

Valve for aerosol containerPatent 7,350,676Issued: April 1, 2008Inventor(s): Di Giovanni; Patrick & Rogerson; Cheryl VanessaAssignee(s): SmithKline Beecham CorporationValve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein. The valve comprises a valve body (1) having at least one orifice (16) to allow a quantity of the suspension to pass from the container into the valve. The valve further comprises a ring (18) disposed around the valve body (1), the ring being positioned below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom, the ring having at least one portion of reduced axial thickness to provide a trough (19) around the valve body below the at least one orifice.

Patent expiration dates:

August 24, 2018

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Drug product

February 24, 2019

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Pediatric exclusivity

Actuation indicator for a dispensing devicePatent 7,500,444Issued: March 10, 2009Inventor(s): Bonney; Stanley George & Brand; Peter John & Godfrey; James William & Rand; Paul KennethAssignee(s): Glaxo Group LimitedAn actuation indicator that includes a drum sub-assembly, which includes a rotatable actuation indicator wheel, a rocking, ratchet pawl for rotating the indicator wheel in a set direction and a rocking mechanism for the pawl driven by a slipping clutch arrangement, is described. The slipping clutch arrangement includes a slipping clutch spring engaged at one end to a pinion of a rack and pinion assembly and at a second end to the ratchet pawl.

Patent expiration dates:

February 26, 2026

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Drug product

August 26, 2026

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Pediatric exclusivity

Actuation indicator for a dispensing devicePatent 7,832,351Issued: November 16, 2010Inventor(s): Bonney; Stanley George & Brand; Peter John & Godfrey; James William & Rand; Paul KennethAssignee(s): Glaxo Group LimitedAn actuation indicator which includes a drums sub-assembly including a rotatable actuation indicator wheel, a rocking ratchet pawl for rotating the indicator wheel in a set direction and a rocking mechanism for the pawl driven by a slipping clutch arrangement, wherein the slipping clutch arrangement includes a slipping clutch spring engaged at one end to a pinion of a rack and pinion assembly and at a second end to the ratchet pawl is described.

Glossary

Term

Definition

Drug Patent

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.

Drug Exclusivity

Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.

RLD

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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